Trial · NCT02540668
A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
NCT02540668, Phase 1, Completed, AstraZeneca; results first posted 2019-03-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants. Trials, record NCT02540668. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02540668
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Drug Interaction Study of Lanabecestat (LY3314814) and Warfarin in Healthy Participants
- NCT number
- NCT02540668
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Healthy
- Interventions
- Lanabecestat, Warfarin
- First posted
- 2015-09-04
- Last updated
- 2019-11-04
- Results first posted
- 2019-03-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Primary | Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Secondary | Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Secondary | Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | |
| Secondary | Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug. | nanogram per milliliter (ng/mL) | GEOMETRIC_MEAN |
| PRIMARY | Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug. | nanogram * hour per milliliter(ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin | Predose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96,120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Pharmacodynamics (PD): Maximum Observed INR Response (INRmax) of Warfarin | Predose, 6, 8, 12, 24, 36, 48, 72, 96, 120, and 144 hours after administration of warfarin on Days 1 and 22 | All participants who received at least one dose of study drug and had evaluable pharmacodynamic INR data on Day 22 of Period 2. | ng/mL | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | Warfarin | 3.50 | Geometric Coefficient of Variation 12 | nanogram per milliliter (ng/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound S-Warfarin | LY3314814 + Warfarin | 3.73 | Geometric Coefficient of Variation 14 | nanogram per milliliter (ng/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | Warfarin | 108 | Geometric Coefficient of Variation 18 | nanogram * hour per milliliter(ng*h/mL) | |
| Pharmacokinetics (PK): Area Under the Concentration Curve 0-∞ (AUC) of Unbound S-Warfarin | LY3314814 + Warfarin | 123 | Geometric Coefficient of Variation 19 | nanogram * hour per milliliter(ng*h/mL) | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | Warfarin | 4.45 | Geometric Coefficient of Variation 11 | ng/mL | |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Unbound R-Warfarin | LY3314814 + Warfarin | 4.80 | Geometric Coefficient of Variation 14 | ng/mL | |
| Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin | Warfarin | 262 | Geometric Coefficient of Variation 18 | ng*h/mL | |
| Pharmacokinetics (PK): Area Under The Concentration Curve 0-∞(AUC) of Unbound R-Warfarin | LY3314814 + Warfarin | 296 | Geometric Coefficient of Variation 18 | ng*h/mL | |
| Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | Warfarin | 160 | Geometric Coefficient of Variation 9 | ng*h/mL | |
| Pharmacodynamics (PD): Area Under the International Normalized Ratio (INR) Versus Time Curve (AUCINR) of Warfarin | LY3314814 + Warfarin | 158 | Geometric Coefficient of Variation 6 | ng*h/mL |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 - Warfarin Single Dose | STARTED | Warfarin | 15 | |
| Period 1 - Warfarin Single Dose | STARTED | LY3314814 + Warfarin | 0 | |
| Period 1 - Warfarin Single Dose | Received at Least One Dose of Study Drug | Warfarin | 15 | |
| Period 1 - Warfarin Single Dose | Received at Least One Dose of Study Drug | LY3314814 + Warfarin | 0 | |
| Period 1 - Warfarin Single Dose | COMPLETED | Warfarin | 15 | |
| Period 1 - Warfarin Single Dose | COMPLETED | LY3314814 + Warfarin | 0 | |
| Period 1 - Warfarin Single Dose | NOT COMPLETED | Warfarin | 0 | |
| Period 1 - Warfarin Single Dose | NOT COMPLETED | LY3314814 + Warfarin | 0 | |
| Period 2 - LY3314814 and Warfarin | STARTED | Warfarin | 0 | |
| Period 2 - LY3314814 and Warfarin | STARTED | LY3314814 + Warfarin | 15 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Retinal haemorrhage | Eye disorders | Warfarin | 0 | 15 | 0 |
| other | Retinal haemorrhage | Eye disorders | LY3314814 | 0 | 15 | 0 |
| other | Retinal haemorrhage | Eye disorders | LY3314814 + Warfarin | 1 | 15 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Warfarin | 1 | 15 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY3314814 | 0 | 15 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | LY3314814 + Warfarin | 0 | 15 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Warfarin | 0 | 15 | 0 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | LY3314814 | 1 | 15 | 1 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | LY3314814 + Warfarin | 0 | 15 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Warfarin | ||
| Total, all-cause mortality | LY3314814 | ||
| Total, all-cause mortality | LY3314814 + Warfarin | ||
| Total, other adverse events | Warfarin | 1 | 15 |
| Total, other adverse events | LY3314814 | 1 | 15 |
| Total, other adverse events | LY3314814 + Warfarin | 1 | 15 |
| Total, serious adverse events | Warfarin | 0 | 15 |
| Total, serious adverse events | LY3314814 | 0 | 15 |
| Total, serious adverse events | LY3314814 + Warfarin | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02540668
GET https://conductscience.org/api/trials/v1/NCT02540668/registered